Clinical trial · Observational
Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in Diagnosis of Cystic Pancreatic Tumors
Evaluation of Image-guided Brushing of Pancreatic Cyst Wall in the Diagnosis of Cystic Pancreatic Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding unavailable
Summary
Brief summary (as posted)
The goal of this study is to compare a sample of the cyst taken by a standard method (fine needle aspiration) to the sample taken by a new method using a device called the EchoBrush to see which method is more accurate at diagnosing cancer. We will also look at proteins (also called biomarkers) in the samples to see if they predict whether or not the cyst is cancerous.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Tumors | Pancreatic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS Guided EchoBrush Sampling | Procedure | — | UNRESOLVED |
| EUS Guided Fine Needle Aspiration | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cystic Pancreatic Tumor Specimens
- description
- Specimen collection via EUS Guided Fine Needle Aspiration EchoBrush Sampling
- interventionNames
- Procedure: EUS Guided Fine Needle Aspiration
- Procedure: EUS Guided EchoBrush Sampling
Primary outcomes (1)
- measure
- Rank The Diagnostic Accuracy of Specimen
- timeFrame
- 12 Months
- description
- The difference in diagnostic accuracy between the cytological grade of dysplasia on aspirated cyst fluid cytology (Specimen/ Group 1) and Echo Brush cytology (Specimen/ Group 2) when compared to surgical histology (Specimen 3). Specifically, the cellularity (scored 0 to 3) of specimen 1 will be compared to specimen 2 using the two-sample proportion test. In addition, the Spearman's rank correlation will be used to calculate the correlation between cytological grade of dysplasia of specimen 1 to specimen 3, and the correlation between specimen 2 to specimen 3.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * All patients must meet clinical criteria to undergo an Endoscopic Ultrasound (EUS) with fine needle aspiration (FNA). * Pancreatic cystic lesion with a minimum diameter of 10 mm noted on a previous cross-sectional imaging modality * All races will be eligible Exclusion Criteria: * Coagulopathy defined as an prothrombin time (PT) \> 13.5 seconds or partial thromboplastin time (PTT) \> 35 seconds * Thrombocytopenia defined as a platelet count \< 50, 000 * Known pancreatic cancer * Recent pancreatitis defined as an episode of pancreatitis within 4 weeks of study enrollment
References
Publications (0)
Data not yet available